Clinical Trial: Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Investigator-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, USP 10 mcg and Vagifem® (Estradiol

Brief Summary: The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the efficacy of each of the 2 active treatments is superior to that of the placebo.

Detailed Summary:
Sponsor: Amneal Pharmaceuticals, LLC

Current Primary Outcome: Responders [ Time Frame: Day 15 (1 day after the administration of the 14th dose of study treatment) ]

A responder was defined as a subject with at least a 25% reduction from baseline in the sum of % basal/parabasal and % intermediate cells on vaginal cytology AND vaginal pH < 5.0 with a change from baseline vaginal pH of at least 0.5, where baseline values were collected at Visit 1


Original Primary Outcome: Same as current

Current Secondary Outcome: Treatment Success [ Time Frame: Day 15 ]

Treatment success was defined as a subject who achieved a score of 0 (none) or 1 (mild) at Visit 3 for the Most Bothersome Symptom (MBS) if her MBS was vaginal dryness, vaginal or vulvar irritation or itching, dysuria or vaginal pain associated with sexual activity, or a result of absence (0) at Visit 3 if her MBS was vaginal bleeding with sexual activity.


Original Secondary Outcome: Same as current

Information By: Amneal Pharmaceuticals, LLC

Dates:
Date Received: January 28, 2013
Date Started: March 2012
Date Completion:
Last Updated: June 25, 2014
Last Verified: June 2014